Michael Vogeser1, Jürgen Kratzsch2, Yoon Ju Bae2, Mathias Bruegel3, Uta Ceglarek2, Tom Fiers4, Alexander Gaudl2, Hedwig Kurka5, Christoph Milczynski6, Cristina Prat Knoll7, Anna C Suhr3, Daniel Teupser3, Ingrid Zahn6, Richard E Ostlund8. 1. Institute of Laboratory Medicine, Hospital of the University of Munich (LMU), Marchioninistr. 15, 81377 Munich. 2. Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital Leipzig, Leipzig. 3. Institute of Laboratory Medicine, Hospital of the University of Munich (LMU), Munich. 4. University Hospital Ghent, Klinische Biologie, Ghent. 5. Roche Diagnostics GmbH, Penzberg. 6. Limbach Laboratory, Medical Care Center, Heidelberg. 7. Roche Diagnostics GmbH, Mannheim. 8. Division of Endocrinology, Metabolism and Lipid Research, Washington University, St Louis, MO.
Abstract
BACKGROUND: Untreated disorders of the adrenocortical system, such as Cushing's or Addison's disease, can be fatal, and accurate quantification of a patient's cortisol levels is vital for diagnosis. The objective of this study was to assess the analytical performance of a new fully-automated Elecsys® Cortisol II assay (second generation) to measure cortisol levels in serum and saliva. METHODS: Four European investigational sites assessed the intermediate precision and reproducibility of the Cortisol II assay (Roche Diagnostics) under routine conditions. Method comparisons of the Cortisol II assay vs. liquid chromatography-tandem mass spectrometry (LC-MS/MS), the gold standard for cortisol measurement, were performed. Cortisol reference ranges from three US sites were determined using samples from self-reported healthy individuals. RESULTS: The coefficients of variation (CVs) for repeatability, intermediate precision, and reproducibility for serum samples were ≤2.6%, ≤5.8%, and ≤9.5%, respectively, and for saliva were ≤4.4% and ≤10.9%, and ≤11.4%, respectively. Agreement between the Cortisol II assay and LC-MS/MS in serum samples was close, with a slope of 1.02 and an intercept of 4.473 nmol/L. Reference range samples were collected from healthy individuals (n=300) and serum morning cortisol concentrations (5-95th percentile) were 166.1-507 nmol/L and afternoon concentrations were 73.8-291 nmol/L. Morning, afternoon, and midnight saliva concentrations (95th percentile) were 20.3, 6.94, and 7.56 nmol/L, respectively. CONCLUSIONS: The Cortisol II assay had good precision over the entire measuring range and had excellent agreement with LC-MS/MS. This test was found suitable for routine diagnostic application and will be valuable for the diagnosis of adrenocortical diseases.
BACKGROUND: Untreated disorders of the adrenocortical system, such as Cushing's or Addison's disease, can be fatal, and accurate quantification of a patient's cortisol levels is vital for diagnosis. The objective of this study was to assess the analytical performance of a new fully-automated Elecsys® Cortisol II assay (second generation) to measure cortisol levels in serum and saliva. METHODS: Four European investigational sites assessed the intermediate precision and reproducibility of the Cortisol II assay (Roche Diagnostics) under routine conditions. Method comparisons of the Cortisol II assay vs. liquid chromatography-tandem mass spectrometry (LC-MS/MS), the gold standard for cortisol measurement, were performed. Cortisol reference ranges from three US sites were determined using samples from self-reported healthy individuals. RESULTS: The coefficients of variation (CVs) for repeatability, intermediate precision, and reproducibility for serum samples were ≤2.6%, ≤5.8%, and ≤9.5%, respectively, and for saliva were ≤4.4% and ≤10.9%, and ≤11.4%, respectively. Agreement between the Cortisol II assay and LC-MS/MS in serum samples was close, with a slope of 1.02 and an intercept of 4.473 nmol/L. Reference range samples were collected from healthy individuals (n=300) and serum morning cortisol concentrations (5-95th percentile) were 166.1-507 nmol/L and afternoon concentrations were 73.8-291 nmol/L. Morning, afternoon, and midnight saliva concentrations (95th percentile) were 20.3, 6.94, and 7.56 nmol/L, respectively. CONCLUSIONS: The Cortisol II assay had good precision over the entire measuring range and had excellent agreement with LC-MS/MS. This test was found suitable for routine diagnostic application and will be valuable for the diagnosis of adrenocortical diseases.
Authors: Marni A Nenke; Anna Zeng; Emily J Meyer; John G Lewis; Wayne Rankin; Julie Johnston; Svjetlana Kireta; Shilpanjali Jesudason; David J Torpy Journal: J Endocr Soc Date: 2017-02-13
Authors: Bradley R Javorsky; Hershel Raff; Ty B Carroll; Alicia Algeciras-Schimnich; Ravinder Jit Singh; Jessica M Colón-Franco; James W Findling Journal: J Endocr Soc Date: 2021-02-18
Authors: Raquel Freitas Zambonatto; Renata Nakata Teixeira; Sarah de Oliveira Poma; Eliane Borges da Silva; Mariana Mendes de Almeida; Gerson Dos Santos Leite; Cesar Miguel Momesso Dos Santos; Heloisa Helena de Oliveira Alves; Renata Gorjão; Tania Cristina Pithon-Curi; Celso R F Carvalho; Rui Curi; Adriana Cristina Levada-Pires Journal: Front Immunol Date: 2021-06-11 Impact factor: 7.561
Authors: G Grassi; V Morelli; F Ceriotti; E Polledri; S Fustinoni; S D'Agostino; G Mantovani; I Chiodini; M Arosio Journal: Hormones (Athens) Date: 2020-03-28 Impact factor: 2.885